Principal Medical Writer

Principal Medical Writer

ICON

Multiple Locations

We are currently seeking a Principal Medical Writer to join our diverse and dynamic team. As a Principal Medical Writer at ICON, you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients’ submissions to regulatory authorities and ensuring compliance with industry standards.

What You Will Be Doing:

• Develop regulatory documents for submission to regulatory agencies globally, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.
• Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
• Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate.

Your Profile:

• A Bachelor's degree in a life science discipline, with Master's degree in life science discipline preferred.
• At least 6 years of medical writing experience in the biopharmaceutical/CRO industry required.
• Regulatory writing experience - Clinical Study Reports, IBs, Protocols
• Oncology experience would be a plus
• Proficient understanding and knowledge of domestic and international regulatory requirements required and knowledge of therapeutic areas in all phases of clinical development desired.
• Proficiency in organizing and communicating clinical information necessary.
• Strong communications, organizational, time management, and project management skills are required.